Vagal nerve stimulation to reduce postoperative delirium in elderly patients
Safety and Feasibility of Transauricular Vagus Nerve Stimulation in Improving Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
This study is testing if a special device that stimulates a nerve can help older patients avoid confusion and memory problems after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06421090 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of perioperative Transauricular vagal nerve stimulation (taVNS) in preventing postoperative delirium (POD) in elderly patients undergoing elective surgery. Participants will be randomly assigned to either receive active taVNS or a control treatment where they wear a taVNS device without stimulation. The study aims to gather data that could support a larger Phase III trial in the future.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older who are scheduled for elective surgery lasting at least 2 hours and expect to stay in the hospital for a minimum of 4 days post-surgery.
Not a fit: Patients undergoing neurosurgery, cardiac surgery, or those with severe cognitive dysfunction or end-stage diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium in elderly patients, improving their recovery and overall outcomes.
How similar studies have performed: While the specific approach of taVNS for POD is novel, similar studies on vagal nerve stimulation have shown promising results in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age≥65 years * Expected operation time≥ 2 hours * Postoperative hospital stay≥ 4 days * Sign the informed consent form Exclusion Criteria: * Neurosurgery or cardiac surgery * Emergency surgery within 6 hours of admission * End-stage disease with an expected survival of \< 3 months * Preoperative severe cognitive dysfunction affected perioperative cognitive function assessment * Severe sinus bradycardia, AVB of degree II and above, pacemaker placement
Where this trial is running
Beijing
- Beijing Tiantan Hospital, Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Ruquan Han, MD
- Email: ruquan.han@ccmu.edu.cn
- Phone: 8610-59976660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.